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NCT00306202 · OUTCOME

Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 1 (Ph+ CP-CML)

Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia · Source last updated 2021-02-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])

What was measured

A participant was said to have a confirmed HR if all the criteria for HR were fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval. HR observed in stratum 1 was CHR. Refer to Outcome Measure 20 for criteria for CHR. The Clopper and Pearson method was used to compute 95% exact CIs.

Analysis population: All treated participants in stratum 1 who received at least 1 dose of dasatinib 60 mg/m\^2.

Groups in this outcome

Stratum1 Ph+ CP-CML (Dasatinib 60 mg/m^2)

Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Stratum1 Ph+ CP-CML (Dasatinib 60 mg/m^2)11

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Stratum1 Ph+ CP-CML (Dasatinib 60 mg/m^2)90.9Not reported58.799.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        58.7
        upper Limit
        99.8
        value
        90.9
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    units
    Participants
description
A participant was said to have a confirmed HR if all the criteria for HR were fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval. HR observed in stratum 1 was CHR. Refer to Outcome Measure 20 for criteria for CHR. The Clopper and Pearson method was used to compute 95% exact CIs.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
    id
    OG000
    title
    Stratum1 Ph+ CP-CML (Dasatinib 60 mg/m^2)
param Type
NUMBER
population Description
All treated participants in stratum 1 who received at least 1 dose of dasatinib 60 mg/m\^2.
reporting Status
POSTED
time Frame
Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])
title
Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 1 (Ph+ CP-CML)
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice